K914150 is an FDA 510(k) clearance for the JANSEN-ANDERSON INSEMINATION SET, a Cannula, Intrauterine Insemination (Class II — Special Controls, product code MFD), submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on September 2, 1992, 352 days after receiving the submission on September 16, 1991. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5250.
| 510(k) Number | K914150 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 16, 1991 |
| Decision Date | September 02, 1992 |
| Days to Decision | 352 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | MFD — Cannula, Intrauterine Insemination |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5250 |